MTS Omadacycline 0.002 - 32 ug/mL

K200180 · Liofilchem s.r.l. · JWY · Mar 20, 2020 · Microbiology

Device Facts

• Record ID: K200180
• Device Name: MTS Omadacycline 0.002 - 32 ug/mL
• Applicant: Liofilchem s.r.l.
• Product Code: JWY · Microbiology
• Decision Date: Mar 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The MTS (MIC Test Strip) Omadacycline 0.002-32 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Omadcycline at concentrations of 0.002-32 ug/mL should be interpreted at 16-20 hours (non-fastidious organisms) and 20-24 hours (fastidious organisms) of incubation.

Device Story

MTS Omadacycline is a quantitative antimicrobial susceptibility test (AST) strip. It consists of paper impregnated with an exponential gradient of omadacycline. The strip is placed on inoculated agar; the antibiotic diffuses into the medium, creating an inhibition ellipse after 20-24 hours of incubation. The MIC is determined by manual visual inspection of the intersection between the inhibition ellipse and the strip. Used in clinical microbiology laboratories to determine the minimum inhibitory concentration of omadacycline against specific fastidious and non-fastidious bacteria. Results guide clinicians in selecting appropriate antibiotic therapy for patients with infections such as CABP or ABSSSI. The device provides a quantitative result that aids in determining bacterial susceptibility, helping to optimize treatment efficacy.

Clinical Evidence

Performance evaluated using 336 clinical and 67 challenge isolates of fastidious Gram-positive and Gram-negative bacteria. Compared against CLSI reference broth microdilution. Overall performance: Haemophilus spp. (98.6% EA, 96.5% CA), S. pneumoniae (91.7% EA, 96.7% CA), S. pyogenes (100% EA, 91.4% CA), and S. anginosus group (100% EA). Reproducibility was 99.3%. Trending analysis identified higher MIC readings for S. pneumoniae, S. anginosus group, and S. pyogenes, which is noted in the labeling.

Technological Characteristics

Specialized paper strip impregnated with a predefined concentration gradient of omadacycline (0.002-32 µg/mL). Manual reading of inhibition ellipse on Mueller Hinton agar + 5% sheep blood. Incubation at 35°C ± 2°C in 5% CO2 for 20-24 hours. Standalone, non-automated, manual interpretation.

Indications for Use

Indicated for in vitro antimicrobial susceptibility testing of specific Gram-positive and Gram-negative bacteria against Omadacycline. Includes S. aureus, S. lugdunensis, E. faecalis, S. pneumoniae, S. pyogenes, S. anginosus group, E. cloacae, K. pneumoniae, H. influenzae, H. parainfluenzae, E. faecium, E. coli, C. freundii, C. koseri, and K. aerogenes.

Regulatory Classification

Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Submission Summary (Full Text)

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March 20, 2020

Liofilchem s. r. 1. % Anne Windau Supervisor Laboratory Specialists, Inc 26214 Center Ridge Road Westlake, Ohio 44145

Re: K200180

Trade/Device Name: MTS Omadacycline 0.002 - 32 µg/mL Regulation Number: 21 CFR 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY-Manual Antimicrobial Susceptibility Test Systems Dated: January 22, 2020 Received: January 24, 2020

Dear Anne Windau:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

## 510(k) Number (if known)

K200180

#### Device Name

MTS Omadacycline 0.002 - 32 µg/mL

#### Indications for Use (Describe)

The MTS (MIC Test Strip) Omadacycline 0.002 - 32 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTSTM consists of specialized paper impregated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum infortory concentration (MC) in ugimL of antimicrobial agents agamst bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Omadacycline at concentrations of 0.002 - 32 ugimL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation.

Omadacycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:

Gram-Positive bacteria Staphylococcus aureus Staphylococcus lugdunensis Enterococcus faecalis Streptococcus pneumoniae Streptococcus pyogenes Streptococcus anginosus group (includes S. anginosus and S. constellatus) Gram-Negative bacteria Enterobacter cloacae Klebsiella pneumoniae Haemophilus influenzae Haemophilus parainfluenzae

Omalacycline has been shown to be active in vitro only against the bacterial species listed below according to the FDA drug approved label:

Gram-Positive bacteria Enterococcus faecium (vancomycin-susceptible and -resistant isolates) Gram-Negative bacteria Escherichia coli Citrobacter freundii

Citrohacter koseri lebstella aerogenes

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) X

Over-The-Counter Use (21 CFR 801 Subpart C)

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